GERMAINE LABORATORIES, INC

Address:11030 Wye Drive,SAN ANTONIO,TX,78217,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzyme Immunoassay, Opiates (DJG) (5) Enzyme Immunoassay, Cannabinoids (LDJ) (4) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Barbiturate (DIS) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (3) Enzyme Immunoassay, Benzodiazipine (JXM) (3) Enzyme Immunoassay, Methadone (DJR) (3) Gas Chromatography, Methamphetamine (LAF) (3) Enzyme Immunoassay, Amphetamine (DKZ) (3) Enzyme Immunoassay, Phencyclidine (LCM) (3) Enzyme Immunoassay, Benzodiazepine (JXM) (1) Enzyme Immunoassay, Propoxyphene (JXN) (1)

Premarket Exempt

No Yes

Clear

SAFECUP II MULTIDRUG 12 - 00695684415228 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-sid Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, mAMP, THC, MTD, MDMA, OXY, OPI, PCP, BAR, BZO, TCA

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DJR, LFG, DIS, LCM, JXM, DKZ, LAF, DIO, DJG, LDJ

Prescription Use : Yes

Device Count : 25

SAFECUP II MULTIDRUG 10 - 00695684415259 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-si Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, mAMP, THC, MTD, OPI, PCP, BAR, BZO, MDMA (cocaine, amphetamine, methamphetamine, marijuana, methadone,opiates, pcp, barbiturates, benzodiazpines, ecstasy).

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DJR, DIS, LCM, DJG, DKZ, JXM, LAF, DIO, LDJ

Prescription Use : Yes

Device Count : 25

AIMSCREEN BUP - 00695684420253 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Buprenorphine (BUP) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

AIMSCREEN BAR - 00695684421250 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Barbiturates (BAR) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DIS

Prescription Use : Yes

Device Count : 25

AIMSCREEN BZO - 00695684423254 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Benzodiazepines (BZO) in urine

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 25

AIMSCREEN COC - 00695684431259 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Cocaine 300 ng/ml in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 25

AIMSCREEN OPI - 00695684441258 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Opiate (OPI) 2000 in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

AIMSCREEN TCA - 00695684442255 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Tricyclic antidepresants (TCA) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LFG

Prescription Use : Yes

Device Count : 25

SAFECUP III 13 PANEL - 00695684444334 Catalog Number :

Device Class : 2

Duns Number: 176458115

Premarket Exempt : No

Product Code : DJG, DIO, DIS, DJR, DKZ, LAF, LCM, LDJ, LFG, JXN, JXM

Prescription Use : Yes

Device Count : 25

AIMSCREEN THC - 00695684451257 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Marijuana (THC) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 25

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